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Committee & Speaker Biographies

Committee & Speaker Biographies

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2020 PDA/FDA Joint Regulatory Conference

The Future is Now: Effective Quality Management and Robust Manufacturing

Sep 14 - Sep 16, 2020 Learn more
  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University then received his Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

    For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions.

    Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Tara Gooen Bizjack

    Tara Gooen Bizjak, MS

    US FDA

    Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service. Tara has been with the FDA for 18 years in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District and transferred to CDER in 2007. Prior to her current role, she was a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CDR Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate. She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.

  • Bing Cai

    Bing Cai, PhD

    FDA

    Dr. Bing Cai is Director of the Division of Liquid-based Drug Products in CDER/OPQ/OLDP at the FDA. In his twenty-year tenure within the FDA, he has been promoted to CDER Senior Review, Team Lead, Chemistry Division Deputy Director and Division Director.  He has been involved in the development of several important Agency’s initiatives, including the current ANDA Integrated Quality Assessment process.  He has coordinated the implementation of the comprehensive review assessment using the Quality by Design and Risk-based Review concepts for various drug dosage forms to ensure a uniform drug quality program across generic and new drug products.

  • Douglas A. Campbell

    InterPro QRA

    Currently a Senior Consultant with InterPro QRA, providing technical services and CGMP guidance to the pharmaceutical industry.  In 2012, completed 14 years of service with the USFDA as a Senior Policy Advisor and Compliance Officer in the International Compliance Branch at CDER Office of Compliance. Also served as the Drug Specialist and a Consumer Safety Officer in the Baltimore District. Doug was a member of the International Inspection Cadre since 2001, and conducted inspections and audits of pharmaceutical manufacturers throughout North and South America, Europe, Asia, and Australia.

    He graduated from Virginia Polytechnic Institute & State University with a B.S. in Science of Food, Nutrition, and Exercise (Pre-Med). He served three years on Active Duty in the U.S. Army.

  • David Chesney

    David L. Chesney, MSJ

    DL Chesney Consulting, LLC

    David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.

    Mr. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

  • Rebecca Devine

    Rebecca A. Devine, PhD

    Biopharmaceutical Consultant

    Rebecca (Becky) Devine, PhD is an independent regulatory consultant with over 30 years of experience in the regulation of biological products. She began consulting in 1999 after leaving the U.S. Food and Drug Administration (FDA). She joined the FDA in 1979 as a Microbiologist, and held various positions in the Center for Biologics Evaluation and Research (CBER) throughout her 20-year FDA career including Associate Director for Policy at CBER. In that position she was responsible for the development and implementation of all regulations, policy and guidance for CBER. Prior to that she was the Associate Director for Regulatory Policy in the Office of Vaccines Research Review, CBER, a reviewer in the Division of Product Certification, and Branch Chief of the Vaccines and Therapeutic Products Branch. Throughout her CBER tenure and consulting career, she has been involved in the review of license applications, inspections, and quality control of vaccine, therapeutic, biotechnology derived biologicals, and cell and gene therapy products. Dr. Devine earned her BS and PhD degrees in microbiology from the University of Maryland. She is currently an active member of the Parenteral Drug Association (PDA) serving as Immediate Past Chair of the Board of Directors.

  • Denise DiGiulio

    Denise M. DiGiulio

    Johnson & Johnson Regulatory

    Denise DiGiulio, Senior Director, Regulatory Compliance Guidance & Outreach Johnson & Johnson Regulatory Compliance

    Denise DiGiulio leads a team that provides strategic direction and support regarding CGMP compliance strategies, new product introductions as well as acquisition support across the enterprise. She has responsibility for ERO (Enterprise Regulatory Outreach), and the Microbiological and Analytical Regulatory Compliance Function. Her team focus is on enhancing regulatory expertise and building partnerships both internally and externally to advance connectivity, transparency while driving agility in regulatory compliance solutions. Denise joined Johnson & Johnson after a twenty-year career with the U.S. Food and Drug Administration where she held roles as ORA field investigatior, and in CDER as compliance officer and process/facility reviewer. While at FDA Denise was a consistent leader in the modernization of FDA’s training, regulations, and inspection procedures and worked on initiatives to integrate drug application review and facility inspection. Denise received her BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in NJ.

  • David Doleski

    David Doleski

    Sanofi

    Mr. David Doleski is the Compliance Head, Biologics Quality Operations for Sanofi. He is responsible for ensuring site readiness for inspections and conformance to regulatory expectations. Prior to Sanofi, David served in FDA for over 27 years, where he progressed through leadership positions related to FDA’s inspection and review programs for drugs and biologics in three Centers (CBER, CDER and Office of the Commissioner). His last position in FDA was Acting Deputy Director for the Office of Process and Facilities (OPF) in CDER, which is an office responsible for performing pre-approval inspections and application reviews. While at FDA, David was part of the leadership team that established the Office of Pharmaceutical Quality (OPQ). He led many initiatives related to inspection programs, especially related to pre-approval inspections, within a number of Compliance Offices and Quality Offices. David has extensive knowledge of FDA inspection and review programs, having participated at all levels, from performing inspections and reviews to leading large groups that implemented those programs. David has Bachelor of Science degrees from Cornell University and University of Maryland University College in biology and computer information systems respectively, as well as graduate work in Systems Engineering at Johns Hopkins University.

  • Rebecca Dombrowski

    Rebecca E. Dombrowski, MS

    FDA

    Rebecca Dombrowski is a Supervisory Investigator in the Office of Regulatory Affairs, Division III. Previously, Rebecca was an Application Reviewer with CDER’s Office of Pharmaceutical Quality, under the Division of Inspectional Assessment, and subsequently, a Compliance Officer with CDER’s Office of Manufacturing Quality. With over 16 years of inspectional experience with the FDA, including 3 years as a District Pre-Approval Manager and 2 years as a Drug Specialist, Rebecca attained Level II and Level III certification as a drug investigator, and became a member of FDA’s Pharmaceutical Inspectorate. She holds a Bachelor of Science and a Master of Science in Biology, and has experience lecturing in both academic and agency forums.

  • Mary Farbman

    Mary E. Farbman, PhD

    Merck & Co., Inc.

    Mary Farbman leads a team of GMP experts responsible for compliance support at Merck’s manufacturing facilities across the globe. She previously worked at FDA/CDER’s Office of Compliance, where she was responsible for authoring and reviewing warning letters and other compliance documents, conducting microbiological reviews of therapeutic protein manufacturing processes, and performing pre-license inspections of BLA products. In industry, she has worked at both the site and global levels in various compliance and auditing roles as well as in the R&D arena. Her areas of expertise and interest include biotechnology, sterile products, and analytical techniques. She holds a doctorate degree in biological chemistry from MIT, where she studied the enzymatic mechanisms of bacterial unfoldases and proteases.

  • Richard Friedman

    Rick L. Friedman, MS

    U.S. FDA

    Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

  • Francis Godwin

    Francis Godwin, MBA

    U.S. FDA

    Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Acting Director for the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug GMP cases.

  • Sharyl Hartsock

    Sharyl D. Hartsock

    Eli Lilly and Company

    Sharyl Hartsock began her 30-year pharmaceutical career with Eli Lilly and Company, where she held various quality leadership roles supporting both parenteral and medical device manufacturing. Through the years, she developed a deep operational understanding of quality systems and aseptic processing needed to ensure sustained regulatory compliance and patient safety. This foundation enabled transition into an enterprise role as the Senior Director of Global Quality Systems in November 2018. In this role, Sharyl has primary responsibility for establishment and maintenance of quality management systems, which include Lilly Quality Standards, practices, business processes, and implementation tools. Prior to that, she was the Senior Director of Quality supporting Indianapolis parenteral manufacturing and new product commercialization. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.

  • Ellen Huang

    Ellen A. Huang

    U.S. FDA

    Ellen Huang is a Senior Advisor in the Office of Biological Products Operations (OBPO) in the Office of Medical Products and Tobacco Operations (OMPTO), at FDA’s Office of Regulatory Affairs (ORA), where she serves as the principle advisor providing direction and oversight on a broad and complex range of programs related to the regulatory enforcement of biological products. Her responsibilities include providing professional expertise, serving as a member of the Program Director’s senior management team and formulating program goals and operating policies.

    Prior to joining ORA, Ellen worked for ten years in FDA’s Center for Biologics Evaluation and Research (CBER). Most of her time in CBER was spent as a Team Leader and Reviewer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ). Her primary responsibilities in DMPQ included providing technical expertise to the division and reviewing facility and equipment information in license applications and supplements for biological products. Ellen also conducted pre-license and pre-approval inspections of biological manufacturing facilities.

    Before joining the FDA, she worked for six years in the biological, pharmaceutical, and medical device industries. Ellen received her B.S. in Industrial and Manufacturing Engineering from The Pennsylvania State University.

  • Mai X. Huynh, MS

    U.S. FDA

    Mai Huynh is the Team Leader of the Antimicrobial Team in the Division of Manufacturing Technologies in FDA - Center for Veterinary Medicine. The Antimicrobial Team is responsible for the review of pre and post-approval applications for veterinary injectable drug products.

    Mai joined CVM in 1989 as a manufacturing reviewer, became a team leader and also a master reviewer for her expertise in sterility assurance validation and modified release injectables. Mai is an active member of the Parenteral Drug Association, and serve as government liaisons for several USP Expert Committees. Mai is a member of several FDA inter-center working groups, and CVM’s Quality Lead on VICH Quality Expert Working Group.

  • David Jaworski

    David J. Jaworski, MBA

    U.S. FDA

    David Jaworski is currently a Senior Policy Advisor in CDER’s Office of Compliance in the Office of Manufacturing Quality and was the 2019 Co-Chair of the PDA FDA Joint Regulatory conference.

    Prior to rejoining the FDA, David worked at Lachman Consultants as a Director in their compliance practice. Previously at FDA, David worked in the Divisions of Domestic Drug Quality and the International Drug Quality where he was a Consumer Safety Officer, Team Leader, and Acting Branch Chief. David also had a distinguished 36 year career in the pharmaceutical and biotech industries where he worked for large pharmaceutical companies as well as small start-up companies. He has broad experience in all aspects of drug product manufacturing, including biotech and small molecule manufacturing, operation of plants, quality management, large project management, and P & L management. He has worked on state of the art technology development projects, and design and construction of world class pharmaceutical plants.

    David received his B.S. in Microbiology from Penn State University, and MBA in Operations & Management from Syracuse University.

  • Jacqueline Kunzler

    Jacqueline A. Kunzler, MBA, PhD

    Baxter Healthcare Corporation

    Jacqueline (Jackie) Kunzler, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation is the Global Head of Quality and Compounding Services, with an organization of 5,500 employees.

    Kunzler joined Baxter in 1993 and has served in roles of increasing responsibility across Baxter’s Research & Development, International Marketing, Quality and Compounding organizations.

    Kunzler obtained her bachelor’s degrees in Biology and Medical Technology (Laboratory Medicine) from University of Iowa. She also received an MS in Toxicology from the University of Florida School of Veterinary Medicine, an MBA from Benedictine University with continuing education at Harvard and Wharton Business Schools, and a Ph.D. in Neuroscience/ Cell Biology from the University of Illinois College of Medicine. She serves on several industry committees and on the Board of Directors of two organizations.

  • Anthony Lorenzo

    Anthony F. Lorenzo

    FDA

    Mr. Lorenzo has been with the FDA since March 2010 in the Office of Compliance and Biologics Quality (OCBQ), Division of' Manufacturing and Product Quality (DMPQ), Manufacturing Branch 2 (MRB 2), Center for Biologics Evaluation and Research (CBER). Prior to joining the Agency, he had 20 years of experience in CGMP manufacturing; designing, building, commissioning, and validating biologic manufacturing facilities; and scaling up pilot scale to large scale manufacturing. Today, Mr. Lorenzo is the Team Lead responsible for planning, coordinating, and evaluating the overall review and approval process for BLAs and supplements in the branch.

  • Carol L. Rehkopf, MS

    FDA

    Carol has worked at FDA for 28 years and is currently Deputy Associate Director for Review Management in CBER. She has experience working in CBER, CDER, ORA & industry leading regulatory experts to develop and execute effective policy and regulatory approaches to submission review, quality systems, and inspections and audits. She holds a Master of Science degree in Regulatory Science from the University of Maryland School of Pharmacy, a Master's Certificate in Project Management from the University of Pittsburgh Katz School of Business, and a Bachelor of Science degree from the University of Maryland University College.

  • Lynnsey Renn

    Lynnsey A. Renn, PhD

    FDA

    Lynnsey Renn is a Public Health Analyst at the U.S. Food and Drug Administration (FDA). She works in the Office of Manufacturing Quality (OMQ) in the Center for Drug Evaluation and Research (CDER) evaluating drug manufacturing facility cases and developing regulatory actions. Dr. Renn joined the FDA in 2011 as a postdoctoral fellow in the Center for Biologics Evaluation and Research (CBER). There she conducted research and worked as part of a team developing a method for lot release testing of allergenic extracts. She also reviewed biologic products intended for the treatment of allergic diseases and served as the Quality Manager for the Allergenic Products Testing Lab. Dr. Renn received a B.S. in Biology from Ursinus College in 2006 and her Ph.D. in Biochemistry and Molecular Genetics from The George Washington University in 2011.

  • Neil A. Stiber, PhD

    FDA

    Neil Stiber is the Associate Director for Science and Communication (acting) in the U.S. FDA’s Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of Surveillance.  During six years at CDER, he has innovated risk-based approaches, provided collaborative program leadership, and engaged stakeholders to advance pharmaceutical quality.  Previously, he was the Director of the Risk Management Staff in the FDA’s Office of Regulatory Affairs and for eight years was an environmental scientist at the U.S. EPA.  Prior to joining the federal government he worked as an environmental consultant specializing in site investigation and risk assessment.  Dr. Stiber received a B.S.E. in civil engineering from Duke University, a M.S. in civil engineering from Northwestern University, and a Ph.D. from the Department of Engineering and Public Policy at Carnegie Mellon University.

  • Valerie Whelan

    Valerie Whelan, BSc

    Amgen Inc.

    Valerie Whelan, Vice President, Head of R&D Quality & Compliance, Amgen Inc. Valerie assumed the role of Head of Quality for R&D in April 2018 with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

    Immediately prior to this, Valerie was the Head of Corporate Quality for Amgen Operations with responsibility for Operations L&P, Corporate QA, Contract Manufacturing Quality, Device Quality, Supplier Quality Management, GxP Computer Related Systems, External Affairs, Partnerships & Alliance Management and Quality oversight of the ATO Manufacturing Site. Prior to this role, she held the role of Site Quality Head for Amgen’s Thousand Oaks manufacturing facility.

    Valerie has over 20 years’ experience in the industry covering a diverse range of pharmaceutical and biotechnology areas both in Europe and the US.

    Prior to joining Amgen in 2011, Valerie held a variety of roles of increasing responsibility within the Quality functions of Pfizer, Bimeda and Takeda. She has accumulated experience in site start up and shut down activities, ongoing new product introduction together with interfacing with a diverse range of Global Inspectorate groups over the course of her career.

  • Kristina Adams

    Kristina M. Adams, PhD

    U.S. FDA

    Kristina Adams is a Drug Product Quality Assessor whose duties include assessment of quality and controls of ANDAs, including large volume parenteral (LVP) IV bags and pre-filled syringes. She also has experience addressing controlled correspondences, advising industry on the adequacy of proposals on the CMC aspects of their ANDA submissions. Prior to joining the FDA, Dr. Adams held roles in synthesis and purification of polymers for biomedical and pharmaceutical applications. She has publications in various peer reviewed journals including Biomaterials and Pharmaceutical Technology. Dr. Adams holds a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry and a BS in Chemistry; both are from the University of Utah.

  • Alina Alexeenko

    Alina Alexeenko, PhD

    Purdue University

    Alina Alexeenko is a professor of Aeronautics and Astronautics and Chemical Engineering at Purdue University. Dr. Alexeenko has been collaborating broadly with industry on design and improvement of lyophilization equipment and processes since 2008 and is a founding co-director of Advanced Lyophilization Technology Hub – LyoHUB established in 2014. Alexeenko received her PhD in Aerospace Engineering from the Pennsylvania State University in 2003 and was a WiSE post-doctoral fellow at University of Southern California from 2004 to 2006. She joined Purdue University faculty as an assistant professor in 2006. Dr. Alexeenko is an associate fellow of AIAA and served as chair of AIAA Thermophysics Technical Committee for 2016-2018. She has authored over 180 journal and conference papers and is a co-inventor on 4 patents. Her research expertise is in computational rarefied gas dynamics, kinetic simulation of gases and plasmas, coupled heat and mass transfer analysis in applications to high-altitude aerothermodynamics, micropropulsion and vacuum technology.

  • Maria Anderson

    Maria C. H. Anderson, MS

    U.S. FDA

    Maria C. H. Anderson works for the U. S. Food and Drug Administration in the Center for Biologics Evaluation and Research (CBER). She has worked in CBER’s Office of Compliance and Biologics Quality for fifteen years. Since 2012, she has served as the Chief of the Biological Drug and Device Compliance Branch within the Division of Case Management. Her branch is responsible for the review and evaluation of compliance and enforcement actions for biological products, drugs, and devices regulated by CBER. The branch also provides assessments of the compliance status of regulated establishments within CBER’s purview, and the branch coordinates CBER’s import and export programs, including review of requests for export of unapproved biological products. Prior to joining FDA, Mrs. Anderson worked as a Biologist with the National Institutes of Health (NIH). During her career at NIH, she earned her Master of Science degree in Biotechnology from Johns Hopkins University. Mrs. Anderson earned her Bachelor of Science degree in Zoology from Howard University.

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    Judith A. Arcidiacono, MS

    U.S. FDA

    Judith Arcidiacono M.S. is an International Regulatory Expert and Standards Liaison for regenerative medicine therapies at the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies (OTAT).

    Judith has 30 years of experience are FDA. In the first 18 years she served as a research/reviewer conducting research on the human immunological response to xenotransplantation products and reviewed clinical trial applications for NK cell and T cell therapies and xenotransplantation products.

    In her current position she works in the Immediate Office of the Director, OTAT, where she is responsible for developing regulatory policy with respect to international harmonization efforts including standards development, and collaborations with global regulatory authorities in the area of regenerative medicine therapies. Ms. Arcidiacono serves on several national and international committees developing standards for regenerative medicine therapies as well as leading international committees focused on harmonization of regulatory approaches for regenerative medicine therapies. Her list of publications include articles and book chapters on her research, FDA policy for standards development and use, and FDA harmonization efforts with international regulators.

  • Donald Ashley

    Donald D. Ashley, JD

    FDA

    As Director of CDER's Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards.

    Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines.

    Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.

    Mr. Ashley earned his law degree from Harvard Law School.

  • Renee Blosser

    Renée S. Blosser, MS

    U.S. FDA

    Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Niya Bowers

    Niya D. Bowers, PhD

    Bill & Melinda Gates Foundation

    Niya Bowers, Senior Program Officer, Integrated Development. Bill & Melinda Gates Foundation. Niya joined the foundation in 2015 as Senior Program Officer in Chemistry, Manufacturing and Controls. She works closely with foundation’s strategy teams and partners to provide technical expertise and strategic guidance for the therapeutic projects.

    Dr. Bowers has over 25 years of experience in pharmaceutical new product development. Her experience covers all areas of CMC development including end-to-end drug substance and drug product analytical, formulation and process, as well as process analytical technology. She also has in-depth experience in regulatory and project management. From 2010 to 2014, she was an executive director at Merck Global Science Technology and Commercialization division responsible for late phase analytical development in both drug substance and drug product. She was also the Head of Merck Global Process Analytical Technology. Before Merck, she was a director of Oral and Specialty Product Development in Schering-Plough.

  • Tia Bush

    Tia L. Bush

    Amgen Inc.

    Tia Bush is the Vice President of Site Operations at Amgen Rhode Island. She is responsible for all operations at Amgen’s 75-acre West Greenwich, RI campus where staff contribute to the manufacture of Enbrel, Vectibix and Repatha and clinical trial materials. She started her career at Amgen in 1992, after obtaining her Biological Sciences and Chemistry degree from the University of Southern California. She is the recipient of Amgen’s Excellence in Quality Award, Providence News “Women in Business-Industry Leader” Award, 2012 Healthcare Business Association Rising Star Award, and in 2017 received Providence Business News’ Outstanding Mentor recognition and in that same year received an award from Governor Raimondo and Million Women Mentors Rhode Island with a Stand Up for Stem award.

  • Cristiana Campa

    Cristiana Campa, PhD

    GSK Vaccines

    Cristiana Campa is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with 20 years’ experience in biologics and related analytical and development strategies, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps.

  • Karyn Campbell

    Karyn Campbell

    AbbVie, Inc.

    Karyn M. Campbell joined AbbVie, Inc. in 2019 upon retiring from the US Food and Drug Administration (FDA) after 36 years of government service. She held several positions at FDA, including Investigator, Compliance Officer, Pre-Approval Manager and, most recently, Director, Investigations Branch II, Division of Pharmaceutical Quality Operations I in FDA’s Office of Regulatory Affairs. Karyn assumed her current role as Senior Director for QA Audit and Compliance in October 2019 and currently works remotely from her home in Blue Bell, PA. In that role, Karyn oversees AbbVie's corporate functional audit staff; she and her team also support sites' inspection readiness activities and regulatory inspections. Karyn obtained a Bachelor of Science degree in biology from Gwynedd-Mercy University.

  • Alonza Cruse

    Alonza E. Cruse

    U.S. FDA

    Alonza Cruse is Director, Pharmaceutical Quality Programs within the Office of Regulatory Affairs. His office is responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine.

    From 2013 - 2015 Mr. Cruse served as the Director, (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within FDA’s Office of Regulatory Affairs where he coordinated ORA’s activities associated with the Generic Drug User Fee Act (GDUFA) implementation and oversaw headquarters inspectional operations associated with pharmacy compounding. Mr. Cruse worked with the Center for Drug Evaluation and Research (CDER)’s senior leadership on initializing ORA’s role in the new drug application review process and the development of a New Inspection Protocols Program.

    In 2000, Mr. Cruse was named Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Prior to this Mr. Cruse was Director, New York District Import Operations.

    Mr. Cruse first joined ORA in 1983 where he began as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

  • John Diehl

    CDR John W. Diehl, MS

    FDA

    CDR John W. Diehl, M.S., is the Director, Compliance Branch, FDA/Office of Regulatory Affairs/Office of Pharmaceutical Quality Operations, Division II. He is responsible for supervising the planning, development, management, and evaluation of compliance and recall matters for FDA regulated pharmaceutical firms located within TX, FL, OK, PR, NC, SC, GA, AL, AR, MS, LA, and TN. Previously, he served as Acting Director, Compliance Branch and the Special Assistant to the Compliance Branch Director in FDA’s Dallas District. Prior to joining FDA/ORA, CDR Diehl served in the Center for Devices and Radiological Health’s (CDRH) Office of Compliance, General Hospital Devices Branch. Prior to working at FDA, CDR Diehl was a Regulatory Specialist for the Biomedical Advanced Research Development Authority within the Department of Health and Human Services/Office of the Secretary.

    CDR Diehl was commissioned as an Officer in the Commissioned Corps of the United States Public Health Service in September, 2008.

    CDR Diehl received his Bachelor of Science degree in Biology from the Catholic University of America, Washington, D.C., and a Masters of Science degree in Biotechnology with a Concentration in Regulatory Affairs from The Johns Hopkins University, Baltimore, MD.

  • Stephanie Durso

    Stephanie Durso, CPH

    U.S. FDA

    Stephanie Durso has been with the Food and Drug Administration for approximately 18 years. She was initially an investigator conducting domestic and foreign inspections, followed by a Compliance Officer, and now, the Director of Compliance Branch for Office of Regulatory Affairs, Office of Pharmaceutical Quality Operations, Division I. In this role, she handles oversight of regulatory actions, including recall activities, for the northeast (from West Virginia to Maine).

  • David Elder

    David K. Elder

    Greenleaf Health

    A 23-year veteran of the FDA and retired Captain in the U.S. Public Health Service (USPHS), David last served as a senior FDA official with prominent roles in domestic and foreign inspections; recalls and emergencies; and compliance actions involving hundreds of situations. He has testified for FDA in federal court and before Congress, initiated and approved enforcement actions, conducted and directed inspections, trained hundreds of FDA investigators, and represented the FDA during national media events. From 1988-2003, David served as an Investigator, Compliance Officer and Compliance Branch Director in the Boston District Office. From 2003-2012, David served in two Senior Executive Service positions at FDA headquarters: Director of the Office of Enforcement (leading the Office with responsibility for compliance policy, enforcement case development, and product recalls), and Director of the Office of Regional Operations (leading the Office with responsibility for policy and operations related to foreign and domestic inspections, import operations, field science, and emergency response). Since leaving FDA in 2012, David has been providing strategic consulting services to pharmaceutical and device companies worldwide, first serving as Vice President with PAREXEL International and for the past four years as Executive Vice President with Greenleaf Health.

  • Richard Glover

    Richard Derek Glover

    Mylan N.V.

    R. Derek Glover serves as the Global Head of Quality for Mylan NV, a leading pharmaceutical company, and has been with Mylan for more than 23 years. Derek is a graduate of West Virginia University, USA where he received a B.S. degree in Chemistry, a B.A. degree in Biology and a B.A. degree in Liberal Arts (science concentration).

    Derek served as a combat medic in the US Army National Guard and the US Army from 1985 to 1993 and he served in Operations Desert Shield and Desert Storm in 1991. After starting his career as a Quality Control chemist, he has previously held various positions of increasing responsibility including, but not limited to, Site Head of Quality Control, Site Head of Quality Compliance, Site Head of Quality, North America Head of Quality, and Global Head of Quality Systems, Compliance and Remediation. He participates in various industry forums and actively partners with regulators and interest groups to shape policy and provide training on topics such as Data Integrity, Laboratory Controls and Process Validation. Derek believes in Mylan’s mission of providing affordable, high quality healthcare to the world’s 7 billion people and works to raise the quality standards for pharmaceutical products everywhere.

  • Andrea Goddard

    Andrea Goddard

    Roche Pharma Technical Operations

    Andrea Goddard (Andi) is currently the Sr. Vice President of Quality and Compliance for Roche Technical Operations and is accountable for quality operations and compliance across the Roche Pharma Network. She is based in Basel, Switzerland.

    Andi has 25 years of experience in the biopharmaceutical industry. Her background includes leadership in manufacturing, floor level operations and manufacturing science and technology before moving into the quality realm.

  • Fernando Gonzalez

    Fernando J. Gonzalez

    U.S. FDA

    Fernando Jose Gonzalez has a Bachelors Degree in International Relations and a Masters in Information Security. He has spent 11 years working with FDA in various capacities, notably in establishing multiple international programs that bring together the FDA's expertise with our international colleagues in promoting Food and Drug Safety.

  • Christine Gray

    Christine E. Gray

    UK MHRA

    Prior to joining the UK Medicines and Healthcare products Regulatory Agency in 2007, Christine Ellen Gray graduated with an B.Sc.(Hons.) degree in chemistry and held a variety of roles in industry. Her work experience spans working in contract research as an analytical chemist, working within DEFRA as a chemist on a variety of research projects and also within contract pre-clinical research as a GLP study director for both ecotoxicology and chemistry studies.

    In her current role Chris is responsible for managing a highly skilled and dynamic team of GMP inspectors, that perform statutory inspections globally, to ensure compliance with Good Manufacturing Practice of pharmaceutical products entering the UK.

    Chris is a specialist in laboratory-based science, has conducted over 300 inspections of UK facilities against GLP/GMP, and continues to perform inspections of regulatory laboratories within MHRA’s inspection programmes.

    Chris has in-depth knowledge of both the application of GLP principles in all types of testing facilities and of EU GMP in a QC testing environment, including contract QC testing, and is a subject matter expert for these activities within MHRA.

    Chris regularly presents at MHRA Symposia and at other external events on a range of topics relevant to regulatory laboratory science.

  • Donna Gulbinski

    Donna Gulbinksi

    Civica Inc.

    Donna Gulbinski’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history of delivering exceptional quality, compliance and business performance.

    Donna has a 30-year plus career where she held positions of significant responsibility for Quality and GxP Compliance, including various roles in drug discovery, operations, quality and regulatory affairs at Merck & Co., Bristol Myers Squibb and Lachman Consultants. Donna is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health systems and philanthropies to address critical generic drug shortages caused by market failures.

  • Marea Harmon

    Marea K. Harmon

    U.S. FDA

    Marea Harmon began her FDA career with the Philadelphia District Laboratory as a cooperative education student and later became an FDA Chemist.  As a Chemist in the laboratory, her work included analyzing pharmaceutical dosage forms, training other analysts, and conducting inspections.  In 2000, Marea became a New Jersey District Investigator at the Voorhees Resident Post.  There she conducted pharmaceutical establishment and laboratory inspections.  Later in her career in 2007, Marea worked as the Drug Training Officer at the Division of Human Resource Development in Rockville, MD.  In 2008, Marea was hired to work at the Center for Veterinary Medicine (CVM), also located in Rockville, MD.   To date, Marea Harmon continues her work at CVM as a Compliance Officer on the Post Market Drug Compliance Team.   

  • Steven Hertz

    U.S. FDA

    Steven Hertz is an officer in FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality. He has been with FDA since 2008 and his work is focused on pre-approval manufacturing assessment for CDER-led and CDRH-led submissions. He has participated on both domestic and international drug product and combination product pre-approval inspections. He is an office subject matter expert for issues regarding computer validation, combination products, control systems, electronic records, bio-pharmaceutical engineering, QbD, PAT, and process validation.

    Mr. Hertz also has 5+ years’ experience working in the biotechnology industry. His previous projects focused on process control, system administration, equipment automation, engineering, risk management, computer system validation, and process validation. He earned his B.S. in chemical engineering from the University of Virginia, his M.S. in biotechnology and his M.B.A. from Johns Hopkins University, and is a licensed Professional Engineer in the state of Maryland.

  • Brooke K. Higgins, MS

    U.S. FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA Center for Drug Safety and Evaluation.  Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, and preparing associated regulatory actions. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District.  While working as the Pre-Approval Manager, she continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

  • Richard Johnson

    Richard Johnson, MS

    PDA

    RICHARD M. JOHNSON was named President and CEO of the Parenteral Drug Association in September 2009. Richard has been an active member of PDA, serving on the Scientific Advisory Board (co-chair); Regulatory Affairs Quality Control committee; Sterile/Aseptic Processing Interest Group (chair); Aseptic Processing committee (co-chair); GMP and Glass Defects (Chair) Task Forces.

    In his more than 30 year career in the pharmaceutical and medical devices industry, Richard has been a recognized leader with excellent knowledge of US and international regulatory requirements, quality practices, and technical operations, especially in validation, sterilization, aseptic and sterile processing.

    Prior positions include Vice President of Global Quality Assurance for Fort Dodge Animal Health (a division of Wyeth), Director of the Corporate Quality Center of Excellence for Abbott Laboratories, and both US and International assignments with Alcon Laboratories and Bausch & Lomb. Richard has M.Sc. and B.Sc. degrees in Biological Sciences from Marshall University. He was also the co-chair of the US Sub-TAG to ISO/TC 198 (Aseptic Processing), and has been active in the PhRMA Bar Code Committee, PQRI Aseptic Processing Working Group, ISPE and the Midwest Quality Discussion Groups since the early 1990’s.

  • Sean McEwen

    Sean McEwen, MA

    AbbVie Inc.

    Sean McEwen is head of the Operations Quality Assurance team for AbbVie. In his current role, Sean leads a team who is responsible for ensuring that all products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Market Authorization. Quality Assurance provides oversight for products, manufacturing processes and plants, quality systems, suppliers, third party manufacturers and global commercial and distribution. The organization plays a key role in developing and maintaining external relationships with our industry peer group and worldwide regulatory authorities.

    Sean joined the Global Pharmaceutical Operations function of Abbott Laboratories in 2004 and held several leadership positions at Abbott/AbbVie in Ireland and in the US including Plant Manager, Divisional Vice President of Regional Quality, Vice President of Biologics Manufacturing and Vice President of Science and Technology. Prior to joining Abbott, Sean spent 2 years at Fluor and 6 years in Merck.

    Sean graduated with a master’s in chemical engineering from the Queens University of Belfast in 1995 and is a Fellow of the Irish Academy of Engineering.

  • Ganapathy Mohan

    Ganapathy Mohan , PhD

    Merck & Co., Inc.

    Ganapathy Mohan leads the Global External Advocacy for Global Quality in Merck Manufacturing Division. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials.

    Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Mohan has a Ph. D in Analytical Chemistry from Kansas State University.

    Mohan was past Chair of the AAPS Regulatory Sciences Section in 2014 and has served in the Council of experts for the United States Pharmacopeia till 2015. He currently serves as the vice chair of the Quality Coordinating Committee of IQ Consortium. He is also the Topic Lead representing PhRMA in the ICH Q13: Continuous Manufacturing of Drug Substances and Drug products Expert Working Group (EWG) and represents Merck in the GQM WG of PhRMA. Mohan leads the PhRMA Nitrosamine Task Force.

  • Susan Neadle

    Susan Neadle

    Johnson & Johnson

    Susan Neadle joined Johnson & Johnson in 1995, where her career includes integral leadership roles in R&D and Quality Engineering/Quality Assurance, spanning pharmaceuticals, medical devices, consumer products. In her current role, Sr. Director, Value Chain Quality Design, she serves as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also leads J&J's Combination Products CoP.

    Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations into J&J's Pharm Sector. Her leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J’s highest honor for innovation excellence. Susan holds numerous patents and publications, and frequently speaks in public venues. She is actively engaged in several industry working groups globally on a range of Combination Products topics. She serves as Chair of the ISPE Combination Products Community of Practice, and as Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry.

  • Douglas Throckmorton

    Douglas R. Throckmorton, MD

    FDA

    As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks.

    Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.

  • Jason Urban

    Jason M. Urban, PhD, CA-AM

    Alexion Pharmaceuticals

    Jason Urban, PhD is Senior Director, Quality Risk Management at Alexion Pharmaceuticals. In this role Jason is responsible for providing risk expertise, driving methodology, focusing on prioritization of risks, and maintaining oversight of enterprise Quality risk registers.

    Jason brings 18 years of leadership across the public and private sectors in the fields of risk management, operations, analytics, and business strategy. Prior to his current role, Jason was with Bristol-Myers Squibb where, as the Head of External Engagement and the Global Process Owner for Risk Management, he led the strategy and implementation of a global GxP Quality Risk Management process network, driving harmonized and standardized approaches to the early identification, mitigation, escalation, and measurement of risk. Prior to this, Jason worked at Celgene Corporation and at the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he led policy and risk program development activities in the areas of supply chain, regulatory compliance, operations, and strategy.

    Jason holds a PhD in Cellular Biology with a focus on oncology and completed his postdoctoral work in molecular neuroscience and cell/gene therapies. Jason is also an active member of the editorial board of Life Science Leader Magazine.

  • Martin VanTrieste

    Martin G. VanTrieste, BS Pharmacy

    Civica Rx

    Retired chief quality officer at Amgen who was most recently named a “Champion of Change” on The Medicine Maker’s Power List for his role in leading Civica, a new, not-for-profit enterprise created to stabilize the supply of essential generic medications.

    Prior to joining Amgen, Mr. VanTrieste was with Bayer Healthcare’s Biological Products Division as vice president of worldwide quality and Abbott Laboratories as the vice president of quality assurance for the Hospital Products Division. Mr. VanTrieste is the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain. He has also served as the Chairman of the Parenteral Drug Association (PDA) Board of Directors.

    PharmaVoice has named Mr. VanTrieste one of the 100 most inspiring people in the pharmaceutical industry, calling him “a man with a mission.” The Medicine Maker has previously named him one of the most influential people in the world of drug development and manufacture saying he “is known throughout industry as a change agent and influencer for his work on advancing pharmaceutical manufacturing, quality and helping to ensure a more reliable supply of high-quality medicines.”

    Earned a Pharmacy degree from Temple University School of Pharmacy.

  • Guy Villax

    Guy Villax

    Hovione

    Guy Villax has been Hovione's CEO since 1997, having previously worked at Price Waterhouse in London and Hovione in Asia.
    Guy Villax was on the EFCG’s Board from 2004 to 2016 being involved in many EFCG advocacy activities: IP, environmental protection, trade issues, quality of medicines and patient safety.
    He testified in 2007 before a US Congress sub-committee on the risks of globalization of the pharma supply chain, falsified medicines and the weak oversight of regulators over API producers located abroad.
    He represented the EU API industry in the negotiations with the US FDA during 2011 that resulted in the Generic Drugs User Fee Act (GDUFA) - for faster approval of ANDAs and a sharp increase in FDA inspections in India and China.
    Guy Villax was a board member of Rx-360 from 2010 to 2017, having been Chair in 2016/17. Guy Villax has a degree in Management from Buckingham University, he is fluent in English, French, Portuguese, Italian and Spanish.
    As a CEO Guy has led Hovione over the last 23 years. Hovione employs over 1800 employees worldwide and stood behind over 18 approvals of new drugs by the FDA between 2015 and 2019.

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2020 PDA/FDA Joint Regulatory Conference

The Future is Now: Effective Quality Management and Robust Manufacturing

Sep 14 - Sep 16, 2020 Learn more